ES2715289T3 - Formulaciones de furina recombinante - Google Patents

Formulaciones de furina recombinante Download PDF

Info

Publication number
ES2715289T3
ES2715289T3 ES12748588T ES12748588T ES2715289T3 ES 2715289 T3 ES2715289 T3 ES 2715289T3 ES 12748588 T ES12748588 T ES 12748588T ES 12748588 T ES12748588 T ES 12748588T ES 2715289 T3 ES2715289 T3 ES 2715289T3
Authority
ES
Spain
Prior art keywords
composition
ppm
sugar
furin
rfurine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES12748588T
Other languages
English (en)
Spanish (es)
Inventor
Meinhard Hasslacher
Andrzej Citkowicz
Catherine White
Ken Franke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxalta GmbH
Baxalta Inc
Original Assignee
Baxalta GmbH
Baxalta Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxalta GmbH, Baxalta Inc filed Critical Baxalta GmbH
Application granted granted Critical
Publication of ES2715289T3 publication Critical patent/ES2715289T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6454Dibasic site splicing serine proteases, e.g. kexin (3.4.21.61); furin (3.4.21.75) and other proprotein convertases
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21075Furin (3.4.21.75)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES12748588T 2011-06-02 2012-06-04 Formulaciones de furina recombinante Active ES2715289T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161492712P 2011-06-02 2011-06-02
PCT/US2012/040790 WO2012167271A1 (en) 2011-06-02 2012-06-04 Formulations of recombinant furin

Publications (1)

Publication Number Publication Date
ES2715289T3 true ES2715289T3 (es) 2019-06-03

Family

ID=46705014

Family Applications (1)

Application Number Title Priority Date Filing Date
ES12748588T Active ES2715289T3 (es) 2011-06-02 2012-06-04 Formulaciones de furina recombinante

Country Status (14)

Country Link
US (2) US8877473B2 (ja)
EP (1) EP2714087B1 (ja)
JP (2) JP5797837B2 (ja)
KR (1) KR102050609B1 (ja)
CN (1) CN103889454B (ja)
AR (1) AR086672A1 (ja)
AU (2) AU2012261813B2 (ja)
BR (1) BR112013030880B1 (ja)
CA (1) CA2837948C (ja)
ES (1) ES2715289T3 (ja)
RU (1) RU2610436C2 (ja)
SG (2) SG195261A1 (ja)
TW (1) TWI586802B (ja)
WO (1) WO2012167271A1 (ja)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6416908B2 (ja) * 2013-08-20 2018-10-31 アドヴァンスド ポリマー モニタリング テクノロジーズ インコーポレイテッドAdvanced Polymer Monitoring Technologies, Inc. 同時複数試料光散乱検出装置及びその方法
TWI743023B (zh) * 2014-05-21 2021-10-21 日商Km生物醫藥股份有限公司 基質金屬蛋白酶 7(mmp-7)聚集體之單體化方法
TWI666319B (zh) * 2014-08-12 2019-07-21 美商巴克斯歐塔公司 在分泌furin之哺乳動物表現系統中生產經完全加工且具功能性之因子X
CN111183151B (zh) 2017-06-23 2024-06-07 武田药品工业株式会社 因子viii亚种的纯化

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL9000917A (nl) 1989-10-25 1991-05-16 Holland Biotechnology Farmaceutisch preparaat met endoproteolytische activiteit; werkwijze voor endoproteolytische processing van (precursor) eiwitten en voor de (micro) biologische bereiding van eiwitten.
EP0785273A1 (en) 1990-11-26 1997-07-23 Genetics Institute, Inc. Paired basic amino acid converting enzyme and DNA sequence encoding it
ZA965368B (en) * 1995-07-14 1997-01-14 Novo Nordisk As A pharmaceutical formulation
AT404838B (de) 1995-11-24 1999-03-25 Immuno Ag Herstellung von proteinen aus pro-proteinen durch fusionsproteine abgeleitet von furin oder furinanalogen
US5876992A (en) * 1996-07-03 1999-03-02 Molecular Biology Resources, Inc. Method and formulation for stabilization of enzymes
US6596526B1 (en) 2000-06-09 2003-07-22 Baxter Aktiengesellschaft Furin polypeptides with improved characteristics
US7033991B2 (en) * 2001-07-16 2006-04-25 Board Of Supervisors Of Louisiana State University And Agriculture And Mechanical College Inhibiting furin with polybasic peptides
TR201809670T4 (tr) * 2003-12-19 2018-07-23 Novo Nordisk Healthcare Ag Faktör VII polipeptitlerinin stabilize edilmiş kompozisyonları.
DE102006008613A1 (de) * 2006-02-24 2007-08-30 Dade Behring Marburg Gmbh Stabilisierte Zubereitungen von Serin-Endopeptidasen, deren Herstellung und Verwendung
PT2157177E (pt) * 2007-05-22 2013-04-18 Baxter Int Processo de purificação preparativo para a furina humana
BRPI0821467B8 (pt) * 2007-12-31 2021-05-25 Baxalta GmbH composição de furina recombinante, método para produzir a composição de furina recombinante, e, método para produzir uma proteína madura utilizando a composição de furina recombinante

Also Published As

Publication number Publication date
TWI586802B (zh) 2017-06-11
EP2714087A1 (en) 2014-04-09
US20120329128A1 (en) 2012-12-27
CN103889454B (zh) 2017-04-05
RU2610436C2 (ru) 2017-02-10
CN103889454A (zh) 2014-06-25
JP5797837B2 (ja) 2015-10-21
AU2012261813B2 (en) 2017-04-20
AR086672A1 (es) 2014-01-15
BR112013030880B1 (pt) 2022-04-12
CA2837948A1 (en) 2012-12-06
AU2012261813A1 (en) 2013-12-19
KR102050609B1 (ko) 2019-11-29
AU2017202050A1 (en) 2017-04-20
KR20140050625A (ko) 2014-04-29
BR112013030880A2 (pt) 2017-06-20
US9662376B2 (en) 2017-05-30
JP2014519506A (ja) 2014-08-14
WO2012167271A1 (en) 2012-12-06
TW201249989A (en) 2012-12-16
US8877473B2 (en) 2014-11-04
RU2013157927A (ru) 2015-07-20
JP6064007B2 (ja) 2017-01-18
US20150079068A1 (en) 2015-03-19
JP2016006106A (ja) 2016-01-14
SG10201604488TA (en) 2016-07-28
CA2837948C (en) 2018-08-21
EP2714087B1 (en) 2018-10-31
SG195261A1 (en) 2013-12-30

Similar Documents

Publication Publication Date Title
US11707524B2 (en) Liquid pharmaceutical composition
ES2810098T3 (es) Preparación liofilizada de toxina botulínica
ES2545893T3 (es) Nuevo agente estabilizante para proteínas farmacéuticas
ES2409032T3 (es) Formulaciones liofilizadas de vwf recombinante
ES2427890T3 (es) Formulaciones estabilizadas de factor IX que contienen trehalosa
ES2694252T3 (es) Métodos para reducir la agregación de IL-1ra
ES2715289T3 (es) Formulaciones de furina recombinante
BRPI0921429B1 (pt) Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável
ES2534334T3 (es) Almacenamiento a largo plazo de G-CSF humano recombinante no glicosilado
CA3214867A1 (en) Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations